TGR-1202 Alone and in Combination With Either Nab-paclitaxel + Gemcitabine or With FOLFOX in Patients With Select Relapsed or Refractory Solid Tumors

A Phase I Study Evaluating the Safety and Efficacy of TGR 1202 Alone and in Combination With Either Nab-paclitaxel + Gemcitabine or With FOLFOX in Patients With Select Relapsed or Refractory Solid Tumors

This is a Phase 1 multi-center study to assess the safety and efficacy of TGR-1202 as a single agent or in combination with nab-paclitaxel + gemcitabine or with FOLFOX in patients with select relapsed or refractory solid tumors.

TGR-1202 will be evaluated alone or in combination with nab-paclitaxel + gemcitabine or with FOLFOX in patients with adenocarcinoma of the pancreas, adenocarcinoma of the colon, rectum, gastric and GE junction cancer, and GI Stromal Tumor (GIST) who have relapsed from or are refractory to prior treatment.

Inclusion Criteria:

• Histologically confirmed:

  1. adenocarcinoma of the pancreas (pancreatic cancer)
  2. adenocarcinoma of the colon or rectum (colorectal cancer)
  3. adenocarcinoma of the gastric (gastric cancer)
  4. esophageal cancer
  5. gastrointestinal stromal tumor (GIST)

• Relapsed or refractory disease

• Measurable lesion by RECIST 1.1

Exclusion Criteria:

• Known Hepatitis B, C or HIV infection
• Previous therapy with any drug that inhibits the PI3K pathway
• Anti-tumor therapy within 21 days of study Day 1